Norwegian Rituximab Chronic Fatigue Syndrome (ME/CFS) Trial Fails

The outcome of a positive Rituximab trial for ME/CFS – possibly, finally, an FDA approved drug, relief for many, acceptance for this disease, increased research fund – would have been spectacular but Dr. Mella reported this week in Norway that the trial unfortunately failed.

The main objective of the Rituximab trial was not achieved but Rituximab’s role with ME/CFS is not necessarily over.

We won’t exactly how it failed until next year but the failure almost certainly means that Rituximab will not be the next FDA approved drug for ME/CFS.

That doesn’t mean Rituximab’s role in ME/CFS is necessarily over, however, and the Rituximab saga has brought much to the ME/CFS field. Read more about it in a Simmaron Research Foundation sponsored blog:

“At some point 50 of the participants reported no need for further infusions, except during times of stress, within six months of starting the infusions. ”

“So how did the authors believe that IV infusions every ten days or so which provided symptom relief for about three days translate into long-term relief? They didn’t know, but their best idea was that IV infusions gave the POTS patients a window to increase their activity levels and relieve the effects of deconditioning that often come with the disease. Ultimately, many didn’t feel the need to have more IV infusions at all.”

=> THE PLACEBO MAY NOT BE THE PLACEBO BUT (part of) THE WORKING INGREDIENT! => Few research is done on long term effect of regular IV saline, so doses and interval in the few trials might have been far less than optimal. Rituximab and Cyclophosphamide chemotherapy may provide better doses and intervals by chance. => If this could be true, optimal dosed IV saline may be cheaper, safer and would need no long test and approval faze.

In my enthusiasm I forgot to mention the study is about POTS patients. Many ME/FM patients however have POTS so improvement in POTS would reduce symptoms and increase abilities for the POTS subgroup present in the trial. The use of IV Saline as a placebo therefore could strongly bias the Rituximab studies outcome (and improve long term health of POTS subgroup patients).

See also “This study has some significant limitations. Because no placebo-controlled group was present, placebo effects may have contributed to the patients’ symptom reduction. The study group was also relatively young (average age mid-30’s) and healthy (few other comorbidities). It’s not clear if ME/CFS/POTS patients were part of the study or not.” in the Saline trial link.

I tried the treatment at a clinic in Mountain View and after 5 infusions I was no better, if anything a little worse.

I think ME is a clumsy umbrella term we have to use for lack of proper biomarkers and testing. So I’m not surprised that for some people the treatment works but for others like me it doesn’t. I strongly think ME sufferers fall across a range of as yet poorly understood causes. I’ve had the condition for close to two decades and it has gotten worse. I’ve spent vast amounts of money on treatments and have come to the realisation that unless there is serious investment in the science to develop reliable biomarkers, progress will at best be marginal.